# DEN240007: BioHealx Anal Fistula Device

- Pathway: De Novo (Direct)
- Applicant: Signum Surgical Limited
- Decided: Jul 1, 2024 after 150 days
- Product code: QML (Anal Fistula Closure Device)
- Device class: 2
- Regulation: 21 CFR 878.4835
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Signum Surgical BioHealx Anal Fistula Device is indicated for closure of the internal opening of mature, cryptogenic, transsphincteric, non-branching fistulas in ano via tissue apposition.

Source page: https://510kreport.com/device/DEN240007
Methodology: https://510kreport.com/methodology